Biopharmaceuticals or Meet the Strict Flight Inspection in History


Release time:

2016-03-23


The problem vaccine cases continue to ferment and maintain a high degree of attention. It is reported that due to the vaccine incident, many provinces and cities have almost fully deployed their drug administration. In addition to implementing the thorough investigation of the problem vaccine by the State Administration, they will also carry out drug storage that requires low-temperature storage of drugs in the near future. Biological products were originally the focus of national and local flight inspections. After the outbreak of the vaccine incident, it is estimated that more stringent flight inspections will be carried out.
Although this news is a rumor, judging from the ginkgo biloba incident last year, it was an incident that triggered a strict investigation of the whole industry. The above statement should not be groundless.
Huge risk of affiliation
For the field of biological products, especially vaccine companies, this vaccine incident has sounded the alarm for the entire industry.
Why is it that the vaccine incident has once again sounded the alarm for the development of the industry?
If you look at the disclosure of the vaccine incident, you will understand.
The vaccine incident was first exposed to 300 people, including 107 online and 193 offline. Zhu Zengfa, deputy inspector of the Shandong Food and Drug Administration, said in an interview with CCTV that from the current investigation, the suspect Pang's illegal operation of the problem vaccine, some of which were purchased by the salesman of a qualified drug production or circulation enterprise.
At present, the country attaches great importance to the safety of food and drugs. The "four strictest" is the principle that the National Bureau adheres to when dealing with related issues. In this context, vaccine cases can be said to have hit the muzzle.
For pharmaceutical companies, strictly prevent drugs from flowing into illegal channels, and for circulation companies, it has once again sounded the death knell for affiliated and ticketing.
In recent years, the upgrading of the tax system, the flight inspection of drug administration, industry and commerce and other departments have ushered in a cold winter for affiliation and passing tickets. Yesterday Cypress Blue and Weiyou shared the one-vote system! Drug companies over the ticket, the end of money laundering? The article analyzes this. In terms of vaccine cases, many of these individuals are able to sell vaccines under the name of pharmaceutical companies.
In the case of a strict investigation of the problem vaccine, whose company is linked to means which company the risk is transferred. Strict investigation and withdrawal of certificates are probably risks that enterprises have to bear. Therefore, if you still want individuals to be affiliated or take tickets in the future, the problem that must be considered is that once you encounter drug quality problems, you will be jointly and severally liable as an affiliated company. It's really risky to invest, so be careful!
Compliance is the mainstream, a drug dealer was withdrawn yesterday.
Pharmaceutical production enterprises should comply with production, and pharmaceutical circulation enterprises should adhere to compliance management. Compliance is still the key word of the pharmaceutical industry this year. Flight inspection has also become an important means to urge the development of industry compliance.
Yesterday, the Guangdong Food and Drug Administration issued a notice on the flight inspection of pharmaceutical companies. The notice stated that Guangdong Hengcheng Pharmaceutical Co., Ltd. was found to have violated the "the People's Republic of China Drug Administration Law" and the relevant provisions of GMP during the flight inspection from January 26 to 27, 2016 after being complained and reported. The provincial bureau decided not to issue the company's new factory area (No. 599 Donghai Avenue, Zhanjiang Economic and Technological Development Zone, Guangdong Province, the acceptance number is 0011000120150198) of the drug GMP certificate (the old factory GMP certificate has expired), and the relevant suspected violations shall be investigated and dealt with by the inspection department according to law.
According to the Guangdong Food and Drug Administration, the above-mentioned enterprises in the flight inspection process of the existence of violations of the facts are:
1. batch production record is not true The traditional Chinese medicine extraction workshop in the old factory of the company is used for the extraction of many varieties of traditional Chinese medicine such as honeysuckle dew. The batch production records show that the same equipment is used to produce different varieties at the same time. For example, on January 6, 2015, R0201A, B and C tanks are used to extract honeysuckle (dew) distillate (1501003), and on January 6, 2015, 11:40-12:40 Use R0201A, B, C three cans to extract orange loquat tablet thick paste (1501003).
2. batch inspection records are untrue
In the gas chromatography identification and detection of honeysuckle dew, some batches of products have the application of detection patterns (such as 1507922 and 1507924,1506921 and 1506922,1508902 and 1508908,1507916 and 1507917).
3. honeysuckle is suspected of illegally adding linalool (flavoring agent), and compound triamcinolone acetonide acetate solution is suspected of illegally adding chemical substances (stabilizers).